Cleared Traditional

K852540 - ULTRASONIC TOOTH SCALER MODEL DSCIOP

K852540 is the FDA 510(k) clearance for ULTRASONIC TOOTH SCALER MODEL DSCIOP by Parkell, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K852540 · Parkell, Inc. · Dental device
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Jul 1985
Decision
17d
Days
Class 2
Risk

K852540 is an FDA 510(k) clearance for the ULTRASONIC TOOTH SCALER MODEL DSCIOP. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Parkell, Inc. devices

Submission Details

510(k) Number K852540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date July 01, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 56
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K852540.
SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
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ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987
CAVI-MED
K842581 · Cooper Lasersonics, Inc. · Aug 1984
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · CooperVision, Inc. · Mar 1984
ROOT CANAL KIT
K811023 · Dentsply Intl. · May 1981